The effect of Lucentis (ranibizumab) on retinal function in diabetic patients with visual impairment and diabetic svelling of the makula

• Conditions: Diabetic makula edema with visual impairment; MedDRA version: 14.0Level: HLGTClassification code 10012653Term: Diabetic complicationsSystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2011-004613-17-SE
• Lead Sponsor: Inst of Ophtalmology Lund University hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with type 1 or 2 diabetes mellitus
patients with clinical significant macular edema
patients with visual impairment <0.7 (Snellen)
Patients with no previous lasertreatment or other treatment for macular edema
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1.Patients with active proliferative retinopathy
2.Duration of macular edema> two years
3.Cataract which causes impaired VA
4.HbA1c > 10 at baseline
5.B-glucos > 20 at baseline
6.Pregnant or nursing women
7.Fertile women not using effective contraception
8.Patients with active och suspected infection in our around the eye
9.Patientes with severe intraocular inflammation
10.Patients with uncontrolled intraocular pressure (IOP) <25 mmHg in spite of treatment 11.Intraocular surgery during the last 3 months befor enrollment
12.Previous treatment for retinaldisease such as trombosis or diabeticretinophaty

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: At baseline one and 3 months after injection with ranibizumab;Main Objective: To study if intravitreal injection of Lucentis gives an improved visual function and a reduction of macularedema. And also objectively evaluate changes in the total retinal function and makular function with mfERG och ff ERG. ;Secondary Objective: To study if Lucentis (ranibizumab) given as an injection into the eye can improv vision and reduce the svelling of the macula. And also to evaluate changes in the retinalcell function and makular cellfunction by using an non-invasive method to measure the electical activity of the retina. ;Primary end point(s): Effect on retinalcell and macular cellfunction of treatment with ranibizumab

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): to study if the changes in retinalfunction correlate to visual improvment and morphology changes on Optical Coherance Tomography (OCT);Timepoint(s) of evaluation of this end point: OCT will be done at baseline, 1 and 3 months after injection with ranibizumab. Visual acuity will be measured at every visit, 0, 1,2,3 months